My client is hiring for an experienced Senior Validations Engineer to join a fast-growing medical device company on a 6-month contract. This role is based in Galway and will support validation activities for the testing and manufacturing of an innovative medical device.
Key Responsibilities:
- Develop and/or approve validation documentation, including protocols, records, and reports.
- Perform and oversee process and test method validation activities.
- Execute validation activities in collaboration with Operations, Quality Assurance, and R&D teams.
- Ensure all validation activities are completed on time and align with project plans.
- Ensure compliance with GMPs and 21 CFR 820 requirements.
- Investigate and resolve validation-related issues.
- Communicate validation results and progress to management.
- Prepare validation summaries for regulatory submissions as required.
What We’re Looking For:
- 5+ years of experience in the medical device or pharmaceutical industry.
- Strong expertise in process and test method validation execution.
- Knowledge of ISO 13485 and 21 CFR 820 requirements.
- Excellent analytical, organisational, and communication skills.
- Ability to work collaboratively and meet project deadlines in a fast-paced environment.
This is a great opportunity to contribute to a cutting-edge medical device project and work within a highly skilled team.